MorphoSys AG

Ladies and gentlemen, good afternoon and good morning. My name is Jula Neugebauer, Head of Investor Relations at Morphosis, and it is my pleasure to welcome you to our fourth quarter and full year 2022 Financial Results Conference call. Joining me on the call today are Jean-Paul Kress, Chief Executive Officer, Zhang Li, Chief Financial Officer, Tim DeMuth, Chief Research and Development Officer, and Joe Horvath, U.S. General Manager, who will join for the Q&A. Before we begin, I'd like to remind you on slide two that some of the statements made during the call today are forward-looking statements, including statements regarding our expectations for the commercialization of our products in our development plans and expectations for the compost in our pipeline, as well as the development plans for our collaboration partners. These forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially. including those described in Morphosis 20F and Annual Report, all for the year ended December 31st, 2022, and from time to time in other SEC documents of morphosis. It is important to keep in mind that our statements in this webcast speak as of today. On slide three, you will find the agenda for today's call. Jean-Paul will begin with an overview and will give an outlook. Then Tim will provide an update on our development pipeline before turning the call to Sang for a summary of our fourth quarter and full year 2022 financial results. Following these prepared remarks, we will open the call for your questions. With that, I now hand the call over to Jean-Paul.

Thank you, Julia. Good morning and good afternoon, everyone. Thanks for joining us today. 2022 was another transformative year for Morphosis. We are determined to have two medicines available to cancer patients by 2025, and we are confident that we will accomplish this. This confidence is reinforced by our clear strategy, highly qualified team, financial strength, and most importantly, a best-in-class mid- to late-stage pipeline. Pelabrasib, our investigational bed inhibitor, represents our largest and most immediate opportunity. This investigational medicine has great potential to improve the standard of care in myelofibrosis. Today, myelofibrosis treatments revolve around the use of JAK inhibitors. These medications focus on relieving symptoms of myelofibrosis rather than treating its cause. But with this treatment strategy, only about 50% of patients achieve adequate symptom control. And for many, that relief fades with time. People suffering from myelophibiosis are in critical need of treatment options that not only address their symptoms, but also act to change the overall course of their disease. Phase 2 results from our manifest study suggest that Pelabrasib, in combination with a JAK inhibitor, may offer prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks. In speaking with physicians who treat myelofibrosis patients, we hear that depth and durability of responses are limited with current first-line therapy. During these conversations, physicians reiterate their excitement about the latest Pelabrasib data and the therapy's potential in helping address their patients' needs. We continue to prioritize the Phase III, Manifest II study of Pelabrasib in myelofibrosis. We look forward to sharing top-line data from this trial in early 2024, in less than a year from now. Beyond myelofibrosis, we also see potential with Pelabrasib in treating other myeloid diseases. We continue to educate the medical community on the efficacy and safety profile of Manjuvi in combination with elanilamide as a treatment for patients with relapsed, refractory, diffuse large B-cell lymphoma, also known as DLBCL. When speaking with treating physicians, we focus our efforts at increasing median time on therapy to achieve the most durable results in the eligible patients. Monjuvi addresses an important need for patients as the only outpatient in-office immunotherapy in second-line DLBCL. We are on track with the number of prescriptions we have seen thus far in 2023. In the future, We also see these established relationships helping us educate physicians on the benefits of Pelabrasib, if it's approved by regulatory authorities, as many of these doctors treat patients with both conditions. We believe the largest opportunity for Monjuvie is yet to come. Beyond the currently approved indication, we are exploring Monjuvi's use in two pivotal studies for patients with first-line DLBCL and for patients with indolent lymphomas. The front-mind study in first-line DLBCL is progressing very well, and we look forward to sharing data from the trial in the second half of 2025. Over the past 12 months, we also took steps to optimize our cost structure and to further strengthen our financial position. This included, for example, the adjustment of our selling expenses or, most recently, the decision to stop work and operations on our preclinical research programs. We continue to concentrate our investments on our most advanced clinical programs that will create near-term value. As part of this focused strategy, last year, we also outlicensed product candidates that are outside our focus in oncology or are in early-stage development. This included a licensing agreement with Novartis for preclinical inhibitors of a new cancer target and with High Bio for Felsartamab and more 210. Under the terms of these agreements, We received competitive upfront payments, and we will be eligible to receive certain milestone payments and royalties. Also, three of our partner programs, Yanalumab, Abelasimab, and Sestrusumab, are now in late-stage clinical development. At the end of last year, we announced that Sang Lee, our chief financial officer, will leave Morphosis at the end of this week. I would like to thank Sung for his contributions and I wish him the best for his future. I am very pleased that Lucinda Crabtree will join Morphosis as our Chief Financial Officer. She will start in the third quarter of 2023 at the latest. Lucinda joins us from Autolus. She is a seasoned executive with broad biotech experience in corporate roles and as an investment professional both on the buy side and the sell side. I would now like to turn the call over to Tim to provide a development update. Tim, over to you.

Thank you, Jean-Paul. In 2022, we advanced our ongoing clinical programs and made great strides. Let's start with Pellabosib. As Rapaul mentioned, the Phase III, Manifest-2 study of Pelabrasib in combination with Raxolitinib in patients with myelofibrosis is our key priority. The trial is progressing well, and we expect to report top-line data in early 2024. The primary endpoint of the study is a proportion of patients who achieve a 35% or greater reduction in spleen volume at week 24, known as SVR35. Reduction in spleen size is used as a clinical endpoint in myelofibrosis because spleen enlargement causes significant pain and is associated with disease activity. The key secondary endpoint of this study is the proportion of patients achieving a 50% or greater improvement in total symptom score. as measured by the myelofibrosis symptom assessment form, or MSAF, from baseline at week 24. Patients with myelofibrosis experience a severely diminished quality of life due to symptoms such as fatigue, fever, and weight loss. The MSAF is a validated tool specifically for myelofibrosis patients that can track changes in these symptoms. Please recall that when we took over the program from Constellation, we optimized the study by increasing the number of patients to approximately 400, and we feel very confident with the improved trial design. The MANIFEST-2 study is supported by findings from the Phase II MANIFEST trial of Pelabrasib in combination with Raxolitinib in patients with myelofibrosis, including those who were JAK inhibitor naive. Updated results from MANIFEST were presented at the ASH annual meeting in December 2022. These results suggest that Pelabrasib in combination with Raxolitinib provides prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks. We also presented preliminary research indicating the association of biomarkers with disease-modifying activity of Pelabrasib. The results from the MANIFEST-2 study were also recently published in the Journal of Clinical Oncology. Based on the body of data we have presented thus far, our confidence in Pelabrasib and the Phase III MANIFEST-2 study is high. Moving on to tefacitamab. This medicine continues to address an important need for patients with relapsed or refractory DLBCL. At the 2023 AACR annual meeting, final data from our pivotal L9 study will be presented during an oral presentation, spotlighting five-year efficacy and safety results in these patients. The results, which build on the data presented at SOHO last year, further support the curative treatment potential of the tefacitimab and lenalidomide combination for patients with DLBCL, as these patients are experiencing durable remissions and long-term responses with treatment. Beyond the currently approved indication, we're exploring tefacitimab in two phase three studies, front-mind and first-mind DLBCL, and in-mind in relapsed or refractory follicular or marginal zone lymphoma, which is being driven by our partner Insight. For about 50% of patients with high intermediate and high-risk DLBCL, the standard of care first-line therapy, RCHOP, is ineffective. And the prognosis for patients with relapsed or refractory disease is very poor. We are investigating the potential of adding tefacitamab and lenalidomide to RCHOP to increase the DLBCL cure rate in the first line and help more patients avoid relapse. At the 2022 ASH annual meeting, we presented final safety and efficacy results from our Phase 1b trial, FirstMind, the precursor study to FrontMind. These results underscore the therapeutic potential of tefacitimab in combination with lenalidomide added onto standard ARTRAP therapy for patients with first-line DOBCL. Finally, let's turn our attention to tomimetastat, our mid-stage investigational next-generation ECH2 inhibitor. Abnormal ECH2 function is implicated in several ways in cancer and may make tumors more resistant to anti-cancer treatment. Tomimetastat is designed to improve on first-generation ECH2 inhibitors to increase potency longer residence time on target, and a longer half-life. Our excitement about this mid-stage program increased in 2022 with the release of early proof of concepts data. Initial data from our Phase I-II basket study showed encouraging monotherapy responses in heavily pretreated patients with ovarian and endometrial cancers, as well as mesothelioma and peripheral T-cell lymphoma. These preliminary results are promising, and we look forward to learning more as the trial progresses. We have a strong mid- to late-stage pipeline. We look forward to sharing pivotal data over the next few years with the manifest two trial results expected in less than 12 months. With that, I now turn the call over to Sun to review the financials.